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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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n/a - 04961333231416

CD, 5105 VERSION 3.3, REV.D
PENTAX OF AMERICA, INC.
7187-7500
In Commercial Distribution

  • 04961333231416 ()


  • Electroglottograph

n/a - 04961333231409

CD, 3650 VER. 3.4.1, REV.F
PENTAX OF AMERICA, INC.
7187-7400
In Commercial Distribution

  • 04961333231409 ()


  • Electroglottograph

n/a - 04961333231379

CD, 4337 VOICE DISORDS DATABA
PENTAX OF AMERICA, INC.
7183-1400
In Commercial Distribution

  • 04961333231379 ()


  • Electroglottograph

Nucleus - 09321502043205

Custom Sound Suite 5.1 CD
COCHLEAR LIMITED
P1257243
In Commercial Distribution

  • 09321502043205 ()
P1257243

  • Audiometric/hearing device software

Actiware - 00606959057753

Actiware, Software CD, US Gov.
Respironics, Inc.
Actiware, Software CD, US Gov. - 6
In Commercial Distribution

  • 00606959057753 ()
1143911

  • Kinesiology ambulatory recorder

Juzo SoftCompress - 00640095288091

SoftCompress Pad, Breast Cup , CD
Julius Zorn, Inc.
6837BR CD
In Commercial Distribution

  • 00640095288091 ()
28809

  • General-purpose medical foam padding, reusable

NA - 00721902378089

TUBING 3048R1 6PK CD PACK
MEDTRONIC, INC.
3048R1
Not in Commercial Distribution

  • 20721902378083 ()
  • 00721902378089 ()


  • Cardiopulmonary bypass system blood tubing set

NA - 00643169841796

SOFTWARE CD S0278-00 NOAHLINK FITTING
MEDTRONIC XOMED, INC.
S0278-00
Not in Commercial Distribution

  • 00643169841796 ()


  • Audiometric/hearing device software

AngelMed Guardian Programmer Application User's Manual CD - 00850012625131

PROG-003 Application User's Manual CD
Avertix Medical Inc.
0204-2100-073#P16
In Commercial Distribution

  • 00850012625131 ()
0204-2100-073#P16

  • Implantable cardiac device management application software

Medtronic Reusable Instruments - 00673978058047

INSTRUMENT 84631 CD LAMINAR ELEVATOR
MEDTRONIC SOFAMOR DANEK, INC.
84631
In Commercial Distribution

  • 00673978058047 ()


  • Bone lever/elevator, reusable
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